Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts
1 other identifier
interventional
200
1 country
1
Brief Summary
This study included cataract patients who underwent intraocular lens (IOL) implantation with or without capsular tension ring (CTR), which aimed to evaluate the contribution of the use of CTR in clinical visual outcomes and rotational stability of IOL after cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedApril 28, 2023
April 1, 2023
2.9 years
August 30, 2022
April 26, 2023
Conditions
Outcome Measures
Primary Outcomes (11)
IOL rotation degree at one hour
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
one hour
IOL rotation degree at 1 day
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
one day
IOL rotation degree at 3 days
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
three days
IOL rotation degree at 1 week
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
one week
IOL rotation degree at 2 weeks
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
two weeks
IOL rotation degree at 1 month
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
one month
IOL rotation degree at 3 months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
three months
IOL rotation degree at 6 months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
three months
IOL rotation degree at 12 months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
three months
Residual astigmatism (RAS) at two weeks
RAS after surgery, which was measured as manifest refraction at two weeks
two weeks
Residual astigmatism (RAS) at one month
RAS after surgery, which was measured as manifest refraction at one month
one month
Secondary Outcomes (15)
visual acuity (VA) at 1 day
two weeks
visual acuity (VA) at 3 days
two weeks
visual acuity (VA) at 1 weeks
two weeks
visual acuity (VA) at 2 weeks
two weeks
visual acuity (VA) at 1 month
one month
- +10 more secondary outcomes
Study Arms (2)
CTR Group
EXPERIMENTALEyes had a capsular tension ring (CTR) implanted into the capsular bag during the cataract surgery.
NCTR Group
NO INTERVENTIONEyes underwent cataract surgery without implanting a CTR.
Interventions
To insert a capsular tension ring during the cataract surgery
Eligibility Criteria
You may qualify if:
- cataract
You may not qualify if:
- preexisting corneal pathology
- small pupil
- glaucoma
- zonular dehiscence
- a history of ocular trauma or surgery
- uveitis
- intraoperative complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031, China
Related Publications (1)
Lin X, Ma D, Han X, Hua Z, Shen W, Qiu X, Cai L, Yang J. Rotational stability of plate-haptic toric intraocular lenses implantation with a capsular tension ring: prospective randomized paired-eye study. J Cataract Refract Surg. 2025 Jan 1;51(1):31-39. doi: 10.1097/j.jcrs.0000000000001554.
PMID: 39353092DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Yang, PhD
Eye & ENT Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 30, 2022
First Posted
September 7, 2022
Study Start
January 1, 2020
Primary Completion
December 1, 2022
Study Completion
March 30, 2023
Last Updated
April 28, 2023
Record last verified: 2023-04